Non-FDA Approved Use for GU/ Kidney Disorder: 60.0% of denials overturned
In 5 California IMR decisions from 2006 to 2009, reviewers overturned 3 (60.0%). 4 were medical-necessity disputes, 1 experimental/investigational.
What the findings mention
From recent overturned decisions
“A 53-year-old male enrollee has requested for Rituxan therapy for treatment of his progressive renal failure. Findings: The physician reviewer found that there is data to suggest that Rituxan may be effective in membranoproliferative glomerulonephritis associated with Type 2 cryoglobulinemia, which is the predominant type of HCV-related glomerulonephritis. It is medically appropriate and reasonable that a trial of Rituxan be …”
“A 32-year-old male enrollee has requested for re-treatment with Rituxan (rituximab for treatment of his minimal change disease (MDC). Findings: Two physician reviewers found that standard therapy for MCD is high dose prednisone, which clearly has long-term toxicities, some of which the patient is currently experiencing. If patients are steroid-dependent, a trial of Cytoxan is indicated. Once this fails, patients …”
“The patient is a 57-year-old male with the diagnosis of Peyronie’s disease. This has reportedly been present for eighteen months and has been associated with erectile dysfunction. In his report from October 2005, the urologist described the patient’s symptoms as reduced (penile) rigidity along with some penile shortening but no significant curvature. The patient is reported as still being able …”
And one the reviewer upheld
“A 37-year-old male enrollee has requested Lovaza for the treatment of his IgA nephropathy. Findings: The physician reviewer found that the FDA approved indication of Lovaza is for adult patients with very high (greater than 500mg/dL) triglyceride levels. This patient had a normal level of creatinine and a low amount of proteinuria. All told, there is insufficient that Lovaza is …”
- California only: these are decisions by independent reviewers under California's IMR program (plans regulated by the Department of Managed Health Care). Other states and self-funded employer plans use different reviewers and rules.
- Selection: only denials that a member took all the way to IMR appear. Most denials are never appealed, and the ones that reach an external reviewer are not a random sample.
- Overturned means the reviewer disagreed with the plan; it does not mean the treatment worked or that a similar request will be approved.
- Argument tags are keyword matches on the reviewer's findings. They describe what the findings mention, not why the case was decided.
- Categories are DMHC's own labels (treatment sub-category and diagnosis category); 'Other' is a catch-all and is excluded from rankings.
Source: California Department of Managed Health Care, Independent Medical Review (IMR) Determinations, Trend (CHHS Open Data). Public California government data; Apellica's aggregates and tags are CC BY 4.0.
Questions
How often were Non-FDA Approved Use denials for GU/ Kidney Disorder overturned?
In 5 California IMR decisions from 2006 to 2009, reviewers overturned 3 (60.0%). 4 were medical-necessity disputes, 1 experimental/investigational.
What should an appeal document, based on these findings?
Whatever the plan's criteria ask for, shown in the record: the treatments already tried and their results, contraindications to the plan's preferred option, the guideline or evidence that supports the request, and the treating clinician's reasoning written to the criteria. The tag table shows which of these the reviewers mentioned most in overturned cases.
Does a California IMR result apply to my plan?
Only California plans regulated by the Department of Managed Health Care go to IMR. Other states and self-funded employer plans use different reviewers, but they weigh the same things.
Independent reviewers reverse plans when the record answers the criteria. Upload the denial letter; a senior reviewer reads it within 24 hours and tells you in writing whether it can be appealed and how. $0 upfront, 10% of what is recovered, nothing if we do not recover. Not a law firm.